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Über diesen Artikel
grade
pharmaceutical analytical impurity (PAI)
agency
USP
API family
ezetimibe
manufacturer/tradename
USP
application(s)
pharmaceutical
pharmaceutical
pharmaceutical small molecule
format
neat
storage temp.
-10 to -25°C
General description
USP PAI are a product line of impurities suitable for research and analytical purposes, which help to ensure the quality and safety of medicines.
Associated Drug Substance: Ezetimibe
Therapeutic Area: Antihyperlipidemics
Application
Features and Benefits
Conduct analytical tests during early formulation feasibility studies.
Determine degradation impurities produced during stress studies.
Develop, validate, and transfer analytical methods.
Perform spiking studies during process R&D to demonstrate depletion upon recrystallization.
Record retention times and/or spectra
Determine relative response factors.
Identify unknown impurities that formed during ICH stability conditions.
Identify impurities that are present in the Reference Listed Drug
Test for and profile impurities not listed in drug substance and drug product monographs.
Analysis Note
1 of 1
Dieser Artikel | |||
|---|---|---|---|
| description Pharmaceutical Analytical Impurity (PAI) | description pharmaceutical analytical impurity (PAI) | description pharmaceutical analytical impurity (PAI) | description United States Pharmacopeia (USP) Reference Standard |
| grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical analytical impurity (PAI) | grade pharmaceutical primary standard |
| manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP | manufacturer/tradename USP |
| application(s) pharmaceutical | application(s) pharmaceutical small molecule | application(s) pharmaceutical small molecule | application(s) pharmaceutical |
| format neat | format neat | format neat | format neat |
| agency USP | agency USP | agency USP | agency USP |
| API family ezetimibe | API family - | API family - | API family ezetimibe |
Lagerklasse
11 - Combustible Solids
Was ist los?
WGK 3
Flammpunkt (°F)
Not applicable
Flammpunkt (°C)
Not applicable
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